Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

Verified by: AstraZeneca, March 2009
First Received: May 2, 2008 | Last Updated: May 26, 2009 | Phase: Phase 3 | Start Date: October 1995
Overall Status: Completed | Estimated Enrollment: 1218
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The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting...

Brief Summary

Official Title: “A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.”

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Bicalutamide
    • 150mg p.o. daily
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: A
  • Active Comparator: B

Outcome Measures for this Clinical Trial

Primary Measures

  • Survival
    • Time Frame: Throughout study period
      Safety Issue?: No
  • Time to clinical progression
    • Time Frame: Throughout study period
      Safety Issue?: No

Secondary Measures

  • Tolerability in terms of adverse events and laboratory parameters
    • Time Frame: Throughout study period
      Safety Issue?: Yes
  • Time to treatment failure
    • Time Frame: Throughout study period
      Safety Issue?: No
  • Prostate-specific antigen
    • Time Frame: Initial study period up to 2005 amended protocol
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Clinical diagnosis of non-metastatic cancer of the prostate gland
  • Patient to be 18 years and above

Exclusion Criteria:

  • Previous systemic therapy for prostate cancer
  • Previous history of another form of cancer (not prostate) within 5 years of study start.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Peter Iversen, MD Principal Investigator Department of Urology Rigshospitalet Copenhagen, Denmark  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672282

Study ID Number: D6876C00025

ClinicalTrials.gov Identifier: NCT00672282

Health Authority: Denmark: Danish Dataprotection Agency

US and Canada only

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00672282